HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 is an FDA 510(k)-cleared medical device (K122857) manufactured by Pegasus Research Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2012. Regulation: 8.